Cleared Traditional

SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER) (K965161) - FDA 510(k) Clearance

Class I Radiology device.

K965161 · Sectra-Imtec AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
79d
Days
Class 1
Risk

K965161 is an FDA 510(k) clearance for the SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER). Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Sectra-Imtec AB (Plano, US). The FDA issued a Cleared decision on March 12, 1997 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2020 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sectra-Imtec AB devices

Submission Details

510(k) Number K965161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date March 12, 1997
Days to Decision 79 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 107d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LMD System, Digital Image Communications, Radiological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.2020
Definition A Medical Image Communications Device Provides Electronic Transfer Of Medical Image Data Between Medical Devices. It May Include A Physical Communications Medium, Modems, Interfaces, And A Communications Protocol. It May Provide Simple Image Review Software Functionality For Medical Image Processing And Manipulation, Such As Grayscale Window And Level, Zoom And Pan, User Delineated Geometric Measurements, Compression, Or User Added Image Annotations. The Device Does Not Perform Advanced Image Processing Or Complex Quantitative Functions.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LMD System, Digital Image Communications, Radiological

All 14
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K965161.
JPACS
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K973131 · Siemens Medical Solutions USA, Inc. · Nov 1997
KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER
K960382 · Eastman Kodak Company · Apr 1996
SIENET SPI SPOOLER
K953552 · Siemens Medical Solutions USA, Inc. · Oct 1995
KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS
K936116 · Eastman Kodak Company · Apr 1994